MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-21 for TOWEL OR 17X24IN BLUE STERILE 6/PK 28700-006 manufactured by Jianerkang Medical Dressing Co.,.
[139439098]
Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident. Or towels are made of cotton, so lint is born and inevitable. The average linting data is 0. 120/ 10 pieces. Six pieces of samples were returned for investigation. There was no lint falling from the sample surfaces. The supplier conducted linting data tests and the linting data is 0. 106g / 6 pieces, which meets the acceptable criteria (=0. 38g/10 pieces). From the investigation, nothing abnormal happened during production and all linting test data was within the acceptable range. Therefore, the root cause for the reported incident could not be determined. The complaint information was provided to the relevant sectors for their awareness. No action will be taken at this time, but we will continue to monitor the trend of this type of incident.
Patient Sequence No: 1, Text Type: N, H10
[139439099]
We had an issue with some sterile blue towels. We were performing an aneurysm coiling case. The wires are laid upon the wet or towels and the wires are then placed into the flush bowl. The sterile blue towels had fuzz come off into our flush bowl. That flush bowl is used to flush the catheters that go into the patient? S brain. There was no injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00292 |
| MDR Report Key | 8439766 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-02-21 |
| Date Facility Aware | 2019-02-21 |
| Date Added to Maude | 2019-03-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DR. |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | JIANERKANG MEDICAL DRESSING CO |
| Manufacturer Street | NO.1, JIANERKANG ROAD ZHIXI TOWN JINTAN CITY |
| Manufacturer City | JIANGSU 213251 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 213251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOWEL OR 17X24IN BLUE STERILE 6/PK |
| Generic Name | TOWEL OR 17X24IN BLUE STERILE 6/PK |
| Product Code | PUI |
| Date Received | 2019-03-21 |
| Returned To Mfg | 2019-03-04 |
| Model Number | 28700-006 |
| Catalog Number | 28700-006 |
| Lot Number | 181006-18-SH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANERKANG MEDICAL DRESSING CO., |
| Manufacturer Address | NO.1, JIANERKANG ROAD ZHIXI TOWN JINTAN CITY JIANGSU 213251 CH 213251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |